ANDA 204680

MYLAN INSTITUTIONAL

FDA Drug Application

Application #204680

Application Sponsors

ANDA 204680

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

20MG/ML

0

HYDRALAZINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-04-28

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204680
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/28\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-04-28
        )

)